Evidence underpinning approval of new cancer drugs raises questions

Around half of trials that supported new cancer drug approvals in Europe between 2014 and 2016 were judged to be at high risk of bias, which indicates that treatment effects might have been exaggerated, according to new study.  The findings from the BMJ add weight to existing research that raises serious concerns about low standards of evidence supporting new cancer drugs, and highlight the need to improve the design, conduct, analysis, and reporting of cancer drug trials. In the European Union, the European Medicines Agency (EMA) is responsible for evaluating the clinical effectiveness and safety of new medicines.  In 2017, more than